Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BioFire Respiratory Panel 2.1 Recalled by BioFire Diagnostics, LLC Due to Due to unintended movement of pouch chemistry, nucleic...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact BioFire Diagnostics, LLC directly.
Affected Products
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Quantity: 23 kits (690 pouches)
Why Was This Recalled?
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About BioFire Diagnostics, LLC
BioFire Diagnostics, LLC has 40 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report